FIELD

The present disclosure relates to the field of employing a fixture for anchoring tubes, drains or dressings to the skin, and enunciates an innovative means for the same.

DEFINITIONS

As used in the present disclosure, the following terms are generally intended to have the meaning as set forth below, except to the extent that the context in which they are used indicate otherwise.

The term “Intubation” refers to insertion of a tube into a patient's body, especially that of an artificial ventilation tube into the trachea.

The term “Naso-tracheal” refers to intubation process performed through the trachea by way of the nasal passage.

The term “Naso-gastric” refers to a tube passed through the nose into the stomach.

The term “Naso-jejunal” refers to a tube that is passed through the nose and threaded across the stomach into the jejunum.

The term “Tracheotomy” refers to an incision in the windpipe made to relieve an obstruction to breathing.

The term “Per-cutaneous Endoscopic Gastrostomy (PEG)” refers to a surgical procedure to pass a tube into a patient's stomach through the abdominal wall.

The term “Cystostomy” refers to a surgical creation of an opening into the bladder.

These definitions are in addition to those expressed in the art.

BACKGROUND

The background information herein below relates to the present disclosure but is not necessarily prior art. Typically, endotracheal tubes, feeding tubes, drainage tubes and dressings are used during or after surgery or in medical patients and require to be fixed on the body at the point of insertion. The conventional method of fixing tubes and drains involves using long strips of adhesive plaster winding around the tube and fixed to the nearby skin, or by stitching the tubes/ drains to the body to prevent accidental slippage or drawing out. A dressing is used to cover wounds and is typically held against the wound by using an adhesive plaster. Further, fixing of tubes, drains or dressings by adhesive plaster frequently results in slippage and accidental extrusion. This can prove dangerous or even fatal during critical situations.

In addition, fixing of tubes, drains or dressings by adhesive plasters result in discomfort, redness, pain and peeling of skin surface in extreme cases. All these skin reactions are described under the title MARSI (Medical adhesive related skin injury), and are dependent upon the duration of use, the tightness of application, pressure points, amount of adhesive plaster used and the quality of adhesive employed. Fixation of tubes, and drains by stitching can produce a pull on the skin where stitches have been passed, causing pain, discomfort and scarring. Moreover, there is definite risk of stitch loosening with possible extrusion of drains, which can be problematic.

There is, therefore, a need for a suitably designed fixture that helps to anchor tubes, dressings and drains and that alleviates the above-mentioned drawbacks.

OBJECTS

Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:

An object of the present disclosure is to provide a fixture for anchoring tubes, drains and dressings to a patient’s body.

Another object of the present disclosure is to provide a fixture that has an innovative design combining adhesive tape in contact with the patient’s skin, a cotton tape to anchor the tubular structure, and an interface between the two.

Yet another object of the present disclosure is to provide a fixture that provides comfort to the patient. Still another object of the present disclosure is to provide a fixture that is cost effective in providing excellent value and minimal wastage terms of manufacturing.

Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

SUMMARY

The present disclosure envisages a fixture for anchoring a tube, drain, or dressing to the skin. The fixture comprises an interface, a cotton tape, and an adhesive tape. The interface has a plurality of first set of slits / holes and at least one second slit configured within it. The cotton tape is configured to be passing through the first set of slits. The tape is further configured to grip a tube, dressing, or drain with the interface. The adhesive tape has a narrow end configured to be fastened to the interface while the other end of the adhesive tape is configured to be pasted to a nearby skin surface, thereby anchoring the tube, dressing, or drain to the skin.

In an embodiment, the tube or dressing or drain is secured to the interface with the cotton tape by tying a knot.

In an embodiment, the material of the interface is selected as plastic (ABS/ poly carbonate), rubber, silicone or metal.

In an embodiment, the first set of slits is perpendicular to the second slit.

In an embodiment, the first end of the adhesive tape is connected to a slit on the interface by a suitable mechanism. In an embodiment, the first end of the adhesive tape is pasted with the second slit.

In an embodiment, the material of tape is selected as silk, cotton and the like.

BRIEF DESCRIPTION OF ACCOMPANYING DRAWING

The fixture for anchoring the tubes, dressings and drains to the skin of the present disclosure will now be described with the help of the accompanying drawing, in which:

Figure 1A illustrates a front view of a tape depicting a narrow end and an adhesive surface;

Figure IB illustrates an enlarged view of the adhesive surface of the tape; Figure 2 illustrates a front view of a cotton tape;

Figure 3 illustrates a front view of an interface having a first set of slits and a second slit;

Figures 4A to 4C illustrate an isometric view depicting narrow end of the tape of Figure 1A being fastened to the second slit of the interface of Figure 3;

Figure 5 illustrates an isometric view of the cotton tape being passed through first set of slits of the interface of Figure 4A leading to formation of the fixture;

Figure 6 illustrates an isometric view the fixture of Figure 5 used for anchoring a nasotracheal tube to the outer portion of nose;

Figure 7 illustrates a front view of an interface having first set of holes and a second slit configured thereon, in accordance with another embodiment of the present disclosure;

Figure 8 illustrates an isometric view of the interface of Figure 7;

Figure 9 illustrates a front view of an interface having different combination of first and second set of slits configured thereon, in accordance with another embodiment of the present disclosure;

Figure 10 illustrates an isometric view of the interface of Figure 9;

Figure 11 illustrates a front view of an interface having plurality of slits configured thereon, in accordance with another embodiment of the present disclosure;

Figure 12 illustrates an isometric view of the interface of Figure 12;

Figure 13 illustrates a graph representing force and displacement relationship of a standard fixing mechanism when subjected to pull while anchoring tube/ dressing/ drain; and

Figure 14 illustrates a graph representing force and displacement relationship of the fixture of the present disclosure when subjected to pull while anchoring tube/ dressing/ drain.

LIST OF REFERENCE NUMERALS USED IN DETAILED DESCRIPTION AND DRAWING

100 - Fixture for anchoring the tubes, dressings and drains 102 - Interface

102 A - Plurality of first set of slits 102B - Second slit

103 - Tape

104 - Adhesive tape 106 - Tube

108 - Nose

DETAILED DESCRIPTION

Embodiments, of the present disclosure, will now be described with reference to the accompanying drawing.

Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well- known techniques are not described in detail.

The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising," “including,” and “having,” are open ended transitional phrases and therefore specify the presence of stated features, operations, elements and/or components, but do not forbid the presence or addition of one or more other features, operations, elements, components, and/or groups thereof.

The terms first, second, third, etc., should not be construed to limit the scope of the present disclosure as the aforementioned terms may be only used to distinguish one element, component, region, layer or section from another component, region, layer or section. Terms such as first, second, third etc., when used herein do not imply a specific sequence or order unless clearly suggested by the present disclosure.

The present disclosure envisages a fixture for anchoring tubes, drains and dressings to the skin. The fixture (hereinafter referred to as “fixture 100”) is described herein below with reference to Figure 1 through Figure 12.

Referring to Figures 1A to 5, the fixture 100 comprises an interface 102, a cotton tape 103, and an adhesive tape 104. The fixture 100 is configured to anchor tubes, drainage tubes, or dressings to the skin, thereby preventing the tube, dressing or drain tube from accidental extrusion/ slippage. Also, the fixture 100 is cost effective in terms of manufacturing.

The interface 102 with a plurality of first set of slits 102 A and at least one second slit 102B are configured on the interface 102. The interface 102 is a small, custom designed component of a specific material. The material used can be a plastic (AB S/poly carbonate), rubber, silicone or metal. It has a plurality of through holes/ slits (102 A, 102B) configured within it. The through holes/ slits (102 A, 102B) are configured to receive the tape 103 such that it allows the tape/ suture 103 to go around the tube, dressing or drain to be fixed firmly. The configuration of slits/ holes (102A, 102B) can be amended for various applications such as for holding or anchoring tubes/ dressings/ drains.

The cotton tape 103 is configured to be passing through the first set of slits 102 A. The cotton tape is further configured to grip either a tube, a dressing, or a drain tube with the interface 102.

The adhesive tape 104 has a narrow end 104A configured to be fastened to the second slit 102B while the other end of the tape 104 is configured to be pasted to a nearby skin surface, thereby anchoring the tube, dressing, or drain to the skin. In an embodiment, the tube or dressing or drain is secured to the interface 102 with the cotton tape 103 by tying a reef knot or a square knot.

The adhesive tape 104 is of a pre-defined length i.e. , which is suitably cut for one end to fix the interface 104 and the tube 106 together, while the other end is pasted on the surface of the skin. The width and the length of the sticky tape 103 will vary with the application. For e.g. in order to fix a nasogastric or a nasotracheal tube, a 1- inch wide tape will be used. For fixation of drains a tape with smaller width will be used. For dressings of wounds on the limbs and torso, wider tapes can be used. In an embodiment, the tape 103 is a high quality hypoallergenic tape (for example DURAPORE by 3M), rectangular in shape, one end of which is suitably shaped and slit to receive the connecting cotton tape 103. The shape of the adhesive tape 104 is shown, and the adhesive surface 104B is covered with suitable backing paper, which can be easily peeled away in order to secure the tape 104 to the chosen area of skin. Shorter lengths of adhesive tapes 104 are included in the pack to cover:

• the area where the tube 106 is tied to the interface 102 with the cotton tape 103; and

• the main adhesive tape 104 after it has been applied to the skin.

In an embodiment, the interface 102 is a small, specially designed plastic object, which on one side connects with the main adhesive plaster, and on the other side, bears parallel slits (102A, 102B) that can admit the longer length of cotton tape 103. The interface 102 is a small, custom designed component of a specific material. The material used can be a plastic (ABS/poly carbonate), rubber, silicone or metal. The tape 103 is to tie the interface 102 with the tube 106 as depicted in Figure 6. However, the fixture 100 can also be used for fixing of various dressings, drains, and tubes. Simply by tying a square knot or reef knot holds the tube, dressing or drain. One end of the interface 102 is aligned with the adhesive tape 104. In an embodiment, the width of the cotton tape 103 is 5 mm. The fixture 100 is used to secure any kind of drain and dressing in similar manner as that used to secure the nasotracheal tube 106.

In an embodiment, the tape 103 can be a cotton tape. In another embodiment, the tape 103 can be a suture material of sufficient length to permit securing of the interface 102 with the tube 106.

In an embodiment, two lengths of a 5 mm cotton tape 103 are used:

• a shorter length of about 3 cm is used as a connector between the adhesive tape 104 and the interface 102; and

• a longer length of about 25 cm is passed across the interface 102 and is used to tie the tube/ dressing to the interface 102.

The cotton tape / equivalent 103, the sticky tape 104, and the interface 102 are configured to securely hold any tube, drain or dressing against a body part. The interface 102 is held firmly by one end of the sticky/ adhesive tape 104, the rest of the tape being fixed on the body of the patient.

The cotton tape 103, the sticky tape 104, and the interface 102 securely hold the tube, dressing or drain in place such that the fixture 100 prevents any tube, drain or dressing from dislodging or accidental extrusion / removal. The assembling of fixture 100 is depicted in Figures 4A to 5. Also, the fixture 100 is used for anchoring a naso-tracheal tube 106 is depicted in Figure 6. In a similar manner, the same fixture 100 can be used for a much finer feeding tube (a Freka tube, size 15).

For example, to secure and hold nasogastric tubes, the fixture 100 involves use of minimum adhesive tape 104 on the flat skin of a nose 108. Beyond this point, there is no adhesive plaster in contact with the delicate alar skin / cartilage, and fixation of the tube 106 is achieved by tying together the tube 106 and the interface 102. This achieves a “water-proof’ junction, which is further covered with a small length of adhesive tape 104 such that secretions from the body do not get anywhere close to the adhesive surfaces or the tube junctions, thereby loosening them. The minimum play achieved due to the distance between the sticky tape and the interface creates increased comfort by avoiding pressure necrosis at the point where the tube normally abuts the nasal ala.

The advantages provided by the fixture 100 are:

• Stability i.e. providing effective anchorage to any kind of tubes, drains and dressings against body; and

• Comfort i.e. by reducing and avoiding excessive adhesive tape contact with the body part.

The removal of the tube, drain or dressing is very simple and pain free, simply by prying the adhesive tape 104 away from the skin. The entire fixture 100 can be removed without causing any discomfort to the patient. More particularly, if the fixture 100 needs to be removed, whilst maintaining the tube 106, it would be best to divide the cotton tape 103 with a blade, between the tube 106 and the interface 102 and disengage the interface 102 from the tube 106. Once this is done, it can be very easily removed and a new one fixed. The fixture 100 minimizes friction, and avoids trauma and maceration of the skin. Even with prolonged use of the tubes, surgical drains and dressings, the fixture 100 holds the tubes, dressings and drains steady, without need for frequent changes of fixation. Further, the amount of adhesive tape 104 used is minimal, allowing a high quality tape 103 to be used in all cases without adding undue cost. The major advantage provided by the fixture 100 is patient comfort. Also, the fixture 100 is useful in situations where dressing materials need to be held against any hairy or irregular body surfaces. The current methods available in market are clumsy and ineffective. The fixture 100 securely holds surgical tubes, dressings and drains such that when subjected to pull it resists the tubes, dressings or drains from slipping out.

In an embodiment, the fixture 100 is suitable in fixation of tubes in applications as follows:

• For patients who are in need of orotracheal or nasotracheal intubation either for surgery, post-op care, or airway control for a variety of reasons including ventilation and airway toilet;

• Naso-gastric/naso-jejunal feeding tubes, fixation of tracheotomy tubes, large drain tubes, surgical drains, indwelling tubes such as Per-cutaneous Endoscopic Gastrostomy (PEG) or supra-pubic cystostomy catheterization; and

• For fixation of endotracheal tubes (nasal/oral) in all patients whether in Operation Theatres or in Intensive Care Units (ICU’s) or Critical Care Units (CCU’s).

The fixture 100 is suitable in fixation of dressings in applications as follows:

• For fixing dressings to cover fungated tumors or open wounds on any part of the body;

• For fixing dressings over joints, mobile areas, hairy areas, and irregular areas such as the face and scalp; and

• For routine fixation of surgical dressings for various needs.

The fixture 100 facilitates easy removal i.e. once the tape 103 is removed from the skin surface; the tube, dressing or drain comes out along with the interface 102 without causing any pain. Once the fixture 100 is removed a new fixture can be easily fixed for securing a tube, drain, or dressing. The fixture 100 can be used to fix dressings over irregular, hairy surfaces without using much adhesive plaster as compared to conventional methods. This helps in avoiding redness, pain and peeling of skin surface. Further, the fixture 100 also eliminates the need of stitching the tubes and drains, thereby avoiding pain and discomfort. In addition, Figure 7 to Figure 12 depicts the interface 102 having holes and/or slits configured thereon which can be used as per requirement. The slits (102 A, 102B) depicted on the interface 102 can be changed for different applications and give very different functionality. For example, the direction of slits (102A, 102B) can be changed, and the slits (102 A, 102B) may be replaced by holes to receive suture material for holding down finer drains, etc.

The entire fixture 100 is presented in a single peel pack that can be sterilized, making it possible to fix tubes/drains safely without risk of contamination and local sepsis.

EXPERIMENT:

Two types of testing were performed to establish proof of safety and efficacy. The first type of testing was carried out externally in a testing laboratory:

In order to test the locking strength of the fixture 100, it was compared with the standard methodology (employing long strips of DYNAPLAST tape) using a tensile testing machine. A standard size 7 endotracheal tube was used and anchored to a testing bench by the two different methods, and a tensile testing machine was used to check “pull strength”. Four readings were taken and the average was calculated.

In the first table (given below) and graph as depicted in Figure 13, it is seen that the standard/ conventional mechanism was able to withstand a force of 17.23 N before breakdown.

TABLE 1

In the second table (given below) and graph as depicted in Figure 14, which represent the fixture 100, test results show a maximum force (i.e. strain) of 47.98 N is necessary for disruption. Such forces are never generated in the clinical scenario.

TABLE 2

The results clearly indicate that as compared with the standard method of fixation, the fixture 100 has superior locking strength.

Also, to evaluate reliability in the clinical scenario, the fixture 100 was employed in a total of 20 cases, 10 endo-tracheal tubes (8 naso-tracheal and 2 oro-tracheal), and 10 naso-gastric feeding tubes. In all patients, just dry skin was ensured, along with a little spray of Cavilon (3M). Amongst all endotracheal tubes for which the fixture 100 was employed, 4 patients were extubated at the end of the procedure, and six were extubated the next day.

All tubes remained well in position, with no cases of slippage or extrusion and the fixation and extubation were uneventful in all cases.

For naso-gastric tubes, there were no cases of loosening which is commonest with the standard method. However, with oily skins, the main adhesive tape applied to the nose came loose and needed replacement. What was notable was the absence of skin reactions and problems with the alar cartilage, even with prolonged tube presence.

Thus, the experimental as well as the clinical data clearly shows that the fixture 100 provides anchoring of tubes/ dressings/ drain tubes and provides comfort to the patients without causing any skin reactions.

The foregoing description of the embodiments has been provided for purposes of illustration and not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment, but are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.

TECHNICAL ADVANCEMENTS AND ECONOMICAL SIGNIFICANCE

The present disclosure described herein above has several technical advantages including, but not limited to, the realization of a fixture for anchoring tubes, drains and dressings, that:

• has an unique but simple design;

• provides comfort to patients;

• is cost effective in terms of manufacturing;

• can be easily removed;

• is used to hold tubes of any size against a chosen part of body; and

• holds/ anchors tubes, dressings and drains in a reliable manner. ECONOMICAL SIGNIFICANCE

One of the objects of the Patent Law is to provide protection to new technologies in all fields and domain of technologies. The new technologies shall or may contribute in the country economy growth by way of involvement of new efficient and quality method or product manufacturing in India.

To provide the protection of new technologies by patenting the product or process will contribute significant for innovation development in the country. Further by granting patent the patentee can contribute in manufacturing the new product or new process of manufacturing by himself or by technology collaboration or through the licensing.

The applicant submits that the present disclosure will contribute in country economy, which is one of the purposes to enact the Patents Act, 1970. The product in accordance with present invention will be in great demand in country and worldwide due to novel technical features of a present invention is a technical advancement in the field of fixtures for anchoring tubes/ dressings/ drain tubes. The technology in accordance with present disclosure will provide product cheaper, saving in time of total process of manufacturing. The saving in production time will improve the productivity, and cost cutting of the product, which will directly contribute to economy of the country.

The product will contribute new concept in fixing or anchoring the tubes, dressings or drain tubes, wherein patented process/product will be used. The present disclosure will replace the whole concept of anchoring the tubes/ dressings/ drains and preventing slipping out from body orifices. The product is developed in the national interest and will contribute to country economy.

The economy significance details requirement may be called during the examination. Only after filing of this Patent application, the applicant can work publicly related to present disclosure product/process/method. The applicant will disclose all the details related to the economic significance contribution after the protection of invention.

The embodiments herein, the various features, and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.

The foregoing description of the specific embodiments so fully reveals the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.

Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, or group of elements, but not the exclusion of any other element, step, or group of elements.

Any discussion of documents, acts, materials, devices, articles or the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application.

While considerable emphasis has been placed herein on the components and component parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.